Create study user accounts

To create a study user in Oracle Clinical One Platform, a Customer Delagated Administrator (CDA) must create an Oracle Life Sciences Single Sign-on (SSO) in Oracle Life Sciences IAMS and assign product roles. Then the user can be added to the appropriate study in Oracle Clinical One Platform.

When you add the user to a study, you must choose the appropriate roles so the user's access to the product allows them to complete their job tasks. Whether the user works at the sponsor, CRO, site, or depot, the workflow for creating the user account is the same.

The first study user is typically added by a product administrator with the Global User Manager or Study Creator roles. Subsequent study users can be added by the study user administrator (which is a special type of study user and typically the first one, added by the product administrator). Refer to Roles in user management.

Workflow for creating an account for a study user

The following table walks you through the tasks for creating accounts for study users.

Note:

Before a CDA can manage users for your organization in Oracle Life Sciences IAMS, they must complete the prerequisites described in Account creation prerequisites. A CDA must also add a product administrator to complete the tasks in this section, see Create product administrator accounts.

Order	Task	Product	User
1	Create the Oracle Life Sciences SSO account for the product administrator. See Create an Oracle Life Sciences Single Sign-On (SSO).	Oracle Life Sciences IAMS	CDA
2	Assign the appropriate product roles. See Assign roles in Oracle Life Sciences IAMS and refer to Roles in Oracle Life Sciences IAMS for all applications. Tip: The CDA at your organization typically assigns product roles to your Oracle Life SSO account. However, if your organization allows self-service registration, users can individually generate a request for product access. To enable self-service registration for specific roles, seeSet up an authorization request page. If self-service registration is enabled, notify users they can request roles as described in Request product roles.	Oracle Life Sciences IAMS	CDA
3	Only required when approval is activated for the given role. Approve the access request to complete product role assignment to the account. Whether the user generated a self-service request, or another CDA manually assigned the product roles for an account. See Review and approve an access request.	Oracle Life Sciences IAMS	CDA with an approver role. Note: You cannot approve your own requests. So if you as a CDA assigned the product role for an account, someone else at your organization with the Approver role must approve them.
4	Create the study roles to be assigned to the user. See: Create a study role at the global level Create a study role at the study level	Oracle Clinical One Platform	Product administrator with the Global User Manager role (global level) Study user administrator (study level)
5	Add the user to the study as described in Add a user to a study in Oracle Clinical One Platform.	Oracle Clinical One Platform	Product administrator with the Global User Manager role Product administrator with the Study Creator role Study user administrator Note: Study Creators are the only users who can assign study users with roles for the study design mode. This means they are the only ones capable to add study user administrators, which are typically the first study users added and who further manage other users at the study level.

CDAs can simplify the process in Oracle Life Sciences IAMS by managing user accounts in bulk. This supports the tasks for creating the SSO account and assigining product roles to it. See Create and manage Oracle Life Sciences Single Sign-Ons (SSO) in bulk.

Study user administrators can simplify the process and add study users in bulk, using the user upload template. With this bulk process you can also create the Oracle Life Sciences SSO account in Oracle Life Sciences IAMS (including the necessary product roles) for users that don't yet have an account. However, study roles must already be created. See Manage study users in bulk.